# K101148: Warm Air Model 135 Hyperthermia System and Blankets

- Pathway: 510(k) (Traditional)
- Applicant: Cincinnati Sub-Zero Products, Inc.
- Decided: Oct 1, 2010 after 161 days
- Product code: DWJ (System, Thermal Regulating)
- Device class: 2
- Regulation: 21 CFR 870.5900
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K904690 (1991). 6 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K942599: Warm Air Warming Unit, Cincinnati Sub-Zero Products, Inc. (1995) Summary page 1.
- K942790: Warm Air Hypertheermia System (Models #130 and #133), Cincinnati Sub-Zero Products, Inc. (1995) Summary page 1.
- K011907: Snuggle Warm 4000 Convective Warming System, Sims Level 1, Inc. (2001)
- K040632: Snuggle Warm 4000 Convective Warming System, Model SW4000, Smiths Medical Asd, Inc. (2004) Summary page 1.
- K960167: System, Thermal Regulating 74-DWJ, Augustine Medical, Inc. (1996) Summary page 1.

## Most influential descendants
- K121669: Warmair Model 135 Hyperthermia System (Controller and Blankets) (2012), 1 descendant of its own
- K123946: Warmair Model 135 Hyperthermia System Including Filteredflo Blankets (2013), 0 descendants of its own

## Recalls of this device
- Jul 20, 2011 · Not classified · Z-3119-2011: Cincinnati Sub-Zero is conducting a field correction due to changes that have been made to the WarmAir Model 135 devices Operation and Technical Manuals in order to comply with FDA device labeling reg
- Jun 1, 2011 · Not classified · Z-2888-2011: Due to its design the circuit breaker on the device could trip causing it to shut down and not provide heated air to the blanket.

## Indications for use
The WarmAir® 135 patient warming system is intended to prevent hypothermia and/or reduce cold discomfort before, during, and after surgical procedures. The thermal regulating system is used to raise a patient's temperature and/or maintain a desired patient temperature through convective heat transfer from the controller to a warm-air-heated blanket. The single-patient use blankets transfer the thermal energy to adult, pediatric or neonate patients to obtain/maintain normal body temperature. It is intended for use by appropriately trained healthcare professionals in clinical environments.

Source page: https://510kreport.com/device/K101148
Methodology: https://510kreport.com/methodology